WATCHMAN Device for Stroke Prevention in Atrial Fibrillation

(ASAP-TOO Trial)

Recruiting at 96 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Scientific Corporation

Must be taking: Aspirin, Clopidogrel

Disqualifiers: Stroke, Heart failure, Mechanical valve, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 7 days

481 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to establish the safety and effectiveness of the WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device, including the post-implant medication regimen, for subjects with non-valvular atrial fibrillation who are deemed not to be eligible for anti-coagulation therapy to reduce the risk of stroke.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but you must be suitable for a specific medication regimen of aspirin and clopidogrel after the device implant. It's best to discuss your current medications with the study team.

What data supports the effectiveness of the WATCHMAN device for stroke prevention in atrial fibrillation?

The WATCHMAN device has been shown to be at least as effective as warfarin (a common blood thinner) in preventing strokes and deaths in patients with atrial fibrillation, according to a study. It is particularly useful for patients who cannot take long-term blood thinners due to bleeding risks. ^{1 2 3 4 5}

How does the WATCHMAN device treatment differ from other treatments for stroke prevention in atrial fibrillation?

The WATCHMAN device is unique because it is a small implant placed in the heart to physically block blood clots from forming in the left atrial appendage, reducing stroke risk without the need for long-term blood-thinning medication like warfarin. This makes it a valuable option for patients who cannot tolerate anticoagulants due to bleeding risks or other complications. ^{1 2 4 5 6}

Research Team

Jacqueline Saw, MD

Principal Investigator

Vancouver General Hospital

Vivek Reddy, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Maurice Buchbinder, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for adults with non-valvular atrial fibrillation who can't take blood thinners. They must be able to take aspirin and clopidogrel after getting the WATCHMAN device implanted, willing to consent, and commit to follow-up visits. Excluded are those needing certain surgeries soon, with severe heart issues or bleeding disorders, pregnant women, or those in conflicting studies.

Inclusion Criteria

I am legally old enough to participate in this study according to my local laws.

I can and will come back for all needed follow-ups.

Two doctors agree I can't take blood thinners by mouth.

Exclusion Criteria

My heart's pumping ability is significantly reduced.

The subject has a life expectancy of less than two years

I plan to undergo a surgery or procedure within 3 months after getting a WATCHMAN device.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the WATCHMAN LAAC Device implant or control treatment with single antiplatelet therapy or no therapy

7 days

1 visit (in-person) for device implantation or control treatment initiation

Follow-up

Participants are monitored for safety and effectiveness, including assessments for stroke, systemic embolism, and major bleeding

5 years

Scheduled follow-up visits as per protocol

Treatment Details

Interventions

• Single Antiplatelet Therapy or No Therapy (Control)
• WATCHMAN LAAC Device Implant

Trial Overview The study tests the WATCHMAN Left Atrial Appendage Closure Device's safety and effectiveness in reducing stroke risk without standard blood thinners. Participants will either receive this implant plus a special medication regimen or no therapy as control.

Participant Groups

Group I: WATCHMAN (Device) Experimental Treatment 1 Intervention

WATCHMAN LAAC Device implant including modified post-implant drug regimen.

Group II: Control Active Control 1 Intervention

Single antiplatelet therapy or no therapy (Control) at the discretion of the study physician for the duration of the trial.

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Findings from Research

The WATCHMAN left atrial appendage closure device is designed to reduce the risk of stroke in patients with nonvalvular atrial fibrillation, but initial studies raised safety concerns leading to a 'not approvable' status from the FDA.

In the subsequent PREVAIL trial, while the device was eventually deemed to have benefits that outweigh risks, updated data indicated a higher incidence of ischemic strokes in the WATCHMAN group (13 strokes) compared to the control group (1 stroke), prompting further review of its safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview of the Food and Drug Administration circulatory system devices panel meetings on WATCHMAN left atrial appendage closure therapy. Waksman, R., Pendyala, LK.[2015]

The WATCHMAN device offers a promising alternative to long-term warfarin therapy for patients with atrial fibrillation (AF) who are at high risk for embolic events but may face complications from anticoagulants, supported by medium-term efficacy and safety data.

This review highlights important technical aspects of WATCHMAN implantation, emphasizing its role as a well-studied option for nonvalvular AF patients who require oral anticoagulation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Watchman Device: Left Atrial Appendage Closure For Stroke Prophylaxis In Atrial Fibrillation. N Obeyesekere Mbbs Mrcp Fracp Fhrs, DM.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Overview of the Food and Drug Administration circulatory system devices panel meetings on WATCHMAN left atrial appendage closure therapy. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Catheter ablation in combination with left atrial appendage closure for atrial fibrillation. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Watchman Device: Left Atrial Appendage Closure For Stroke Prophylaxis In Atrial Fibrillation. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Left Atrial Appendage Occlusion Complicated by Appendage Perforation Rescued by Device Deployment. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Left atrial appendage closure device implantation in patients with prior intracranial hemorrhage. [2020]

6. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Left Atrial Appendage Closure -The WATCHMAN Device. [2020]